Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478517
Status:
WITHDRAWN
Last Update Posted:
2009-03-11
First Post:
2007-05-23
Brief Title:
TETRAM 2 Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit Maximum Tolerated Dose Study
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Treatment With Erythropoetin in Patients With Spinal Trauma With Neurological Deficit Maximum Tolerated Dose Study TETRAM2
Status:
WITHDRAWN
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TETRAM2
Brief Summary:
The social psychological economic burden of Spinal trauma with deficit is great and there is no curative treatment
Erythropoetin EPO is promising due to its neuroprotective effects demonstrated in vitro in vivo in animal models and in a preliminary study including patients with stroke
The study primary end point is to find out the maximum tolerated dose of EPO This is based on the occurrence of pulmonary embolism during a 14 day delay following EPO injection Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid CSF study of EPO effects on several inflammatory and apoptotic bio markers and blood cell counts
The experimental design is a dose scale study 600 to 2400 UIKg using a single dose of rHuEPO EPREX The EPO dose is defined using a Bayesian continuous reassessment Method CRM The sample size is expected for less than 20 patients
Eligible patients are patients aged 15 to 65 years able to receive the EPO injection within 12 hours of a spinal trauma without vital blood loss or associated diseases The follow-up lasts 6 months
Erythropoetin EPO is promising due to its neuroprotective effects demonstrated in vitro in vivo in animal models and in a preliminary study including patients with stroke
The study primary end point is to find out the maximum tolerated dose of EPO This is based on the occurrence of pulmonary embolism during a 14 day delay following EPO injection Secondary end points include comparisons of EPO kinetics in blood and cerebrospinal fluid CSF study of EPO effects on several inflammatory and apoptotic bio markers and blood cell counts
The experimental design is a dose scale study 600 to 2400 UIKg using a single dose of rHuEPO EPREX The EPO dose is defined using a Bayesian continuous reassessment Method CRM The sample size is expected for less than 20 patients
Eligible patients are patients aged 15 to 65 years able to receive the EPO injection within 12 hours of a spinal trauma without vital blood loss or associated diseases The follow-up lasts 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None